MasterControl - Quality & Compliance Management PodCast

About this podcast

This PodCast is dedicated to all thing quality management and features experts from around the world.

MasterControl - Quality & Compliance Management PodCast

Episodes

2021
Navigating Constant Change With Flexible Quality Systems
Since the COVID-19 pandemic started over a year ago, businesses have learned that constant change is the new normal. There will always be outside forces that companies need to adapt to, many of which are unforeseen, and there’s a continual need for resilience. One of the things that MasterControl customers have noticed is how going digital and using our solutions helps them when these issues arise. They can communicate more effectively, keep their operations going, and maintain quality with minimal interruption. We’ve already moved our customers from paper to digital — now we’re focused on data intelligence. Data intelligence is all about using artificial intelligence (AI) and machine learning (ML) to make data-driven decisions. Or, in some cases, simply enabling the applications to make those decisions without human involvement. This level of connectivity brings quality into every part of your organization, giving you a true culture of quality. Key takeaways from this session include: How common quality pains are solved by digitizing. How a connected platform allows improved agility/resilience. The benefits of connecting quality data and using it to drive decision-making. How a culture of quality driven by connected data and metrics can help your business thrive.
February 5, 2021
54 min
Manufacturing Technology: Features and Functionality for Changing Environments
COVID-19 has exposed issues within the manufacturing industry, which may never be the same. The global pandemic illustrates why it is critical for manufacturers to be adaptable. Forward-thinking companies need to adopt the right technology now to ensure they can adapt to the current environment and prepare for the future.
February 5, 2021
65 min
The Rise of Intelligent Quality: Shifting to Flexible and Dynamic Processes
The traditional approach to quality in the life sciences has mainly been focused on control and standardization. As the industry continues to evolve, companies are finding it necessary to incorporate flexibility and improved collaboration into their quality management methodologies. These shifts are creating exciting opportunities to leverage emerging technologies like artificial intelligence, machine learning and natural language processing for data collection, analysis and connectivity.
February 5, 2021
37 min
The New Ecosystem Dynamics: Digitization as a Driver of Global Quality Alignment and Innovation
Outsourcing isn’t a trend in the life sciences – it’s the new way of doing business. MasterControl Executive Vice President of Product Matt Lowe discusses the challenges posed by modern business ecosystems and the criticality of extensible and flexible quality management systems. Lowe will examine the many ways technology platforms can help companies expand quality’s footprint while also enhancing their control over operations and data. He is joined by Matthew Seitz-Paquette of Fagron who will examine some real-world applications and show the power of QMS extensibility by explaining how the personalized medicine and compound pharmaceutical company has leveraged advanced digital tools to align quality processes between multiple global sites and streamline its training processes. Lowe and Seitz-Paquette will share examples of the benefits that can be achieved by effectively connecting quality data and processes with robust platforms.
February 5, 2021
55 min
Episode 10: Future Proofing – Digital Production Records, QMS and Validation
Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 10 of this 10-part series, SVP of Strategic Growth Brian Curran and Principal Product Management Director Terrance Holbrook talk about how to stay flexible for future changes by digitizing. Key takeaways include: • The adaptability of a digital production records system. • What to look for in a quality management system (QMS). • The benefits of risk-based validation.
February 4, 2021
18 min
Episode 9: Future Proofing – Continuing Production Beyond Exemption
Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 9 of this 10-part series, Senior Director Public Relations and Content Jennifer Hurst and Principal Product Management Director Terrance Holbrook talk about how digitizing will help companies prepare for the aftermath of the pandemic. Key takeaways include: • How the pandemic has shaped exemptions. • What companies can do once the pandemic has resolved. • How a culture of quality prepares your company for the future.
February 4, 2021
20 min
Episode 8: Documentation – Quality Event Management and Audit
Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 8 of this 10-part series, Product Manager Kim Jackson and Principal Product Management Director Terrance Holbrook talk about digitizing quality event management and how it can improve an organization. Key takeaways include: • Importance of process improvement in QEM. • Problems solved by digitizing QEM. • Factors to keep in mind while digitizing.
February 4, 2021
24 min
2020
Episode 7: Documentation – Electronic Batch and Device History Records
Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 7 of this 10-part series, Product Manager Katie Farley and Principal Product Management Director Terrance Holbrook talk about best practices for and benefits of digitizing manufacturing. Key takeaways include: • How to start your digital journey. • Design best practices for optimizing master batch records and DHRs. • How connected data helps you achieve OKRs and KPIs.
October 13, 2020
23 min
Episode 6: Documentation – Standard Operating Procedures (SOPs) and Work Instructions
Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 6 of this 10-part series, Product Manager Katie Farley and Principal Product Management Director Terrance Holbrook talk about digitizing your SOPs and work instructions. Key takeaways include: • How to digitize your SOPs and work instructions. • The biggest challenges and how to overcome them. • The benefits of going digital.
October 12, 2020
19 min
Episode 5: FDA Current Guidance and Exemptions
In Episode 5 of this 10-part series, Product Owner Manager Dave Latimer and Principal Product Management Director Terrance Holbrook talk specifically about how digitizing helps with the complexity of compliance. Key takeaways include: How to be audit ready. Requirements of 21 CFR 210-211. How digitizing streamlines processes.
August 21, 2020
17 min
Episode 4: ISO vs. cGMP vs. FDA Requirements
In Episode 4 of this 10-part series, Product Owner Manager Dave Latimer and Principal Product Management Director Terrance Holbrook discuss FDA requirements and how to comply with them. Key takeaways include: Bridging the gap between quality and manufacturing. Improving compliance processes. Enhancing best practices to avoid common pain points.
August 21, 2020
18 min
Episode 3: Achieving and Maintaining an Audit-Ready State
In Episode 3 of this 10-part series, Validation Product Manager Erin Wright and Principal Product Management Director Terrance Holbrook discuss how companies can be prepared for an audit at any time. Key takeaways include: Determine what’s keeping you from becoming audit ready. Tools to help you overcome those barriers. How to maintain an audit-ready state.
August 10, 2020
21 min
Episode 2: Elevate Your Quality Management System
Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 2 of this 10-part series, SVP of Strategic Growth Brian Curran and Principal Product Management Director Terrance Holbrook discuss the cost benefits of a QMS. Key takeaways include: • The cost of a QMS is an investment. • The cost savings from having a good QMS. • The associated cost reductions.
August 7, 2020
18 min
Episode 1: An Introduction to Quality Management System (QMS) for Regulated Industry – Next Steps
Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 1 of this 10-part series, Vice President of Product Rajesh Talpade and Principal Product Management Director Terrance Holbrook explain the basic ins and outs of optimizing a QMS. Key takeaways include: • How to expand your QMS. • Why paper slows down production. • The responsibilities of management.
August 7, 2020
16 min
Cloud Security Myths - Part 2 Security and Validation Webinar Series
This webinar dispels the most common myths about cloud security, such as it is still an immature technology, storing data on your own server is safer, cloud service providers don’t understand the specific data management needs of regulated companies, and more.
March 19, 2020
52 min
Cloud Education - Part 1 Cloud Security and Validation Webinar
Everyone’s talking about the importance of the cloud, but how much do you actually know about it? Because misconceptions abound, we’ve put together a webinar series to cover cloud basics and put to rest any fears you might have about migrating. MasterControl EVP of Customer Success Adam Decaria and GxP-Compliance Consulting CEO James Francum explain cloud environments, the business case for migrating, and how the cloud is affecting the life sciences industry.
March 19, 2020
59 min
2019
Standardize Your On The Job (OJT) With TWI” by Roger Crist
Description: Roger Crist, a career quality and compliance professional and the quality director at MOXTEK, presents “Standardize Your OJT With TWI” to help illustrate how training impacts quality. Crist demonstrates how on the job training (OJT) when paired with training within industry (TWI) instills in a life sciences or other regulated manufacturer the priorities and company culture of safety, quality and productivity. A standardized approach to OJT can be a key to minimizing and preventing human error on the shop floor that can slow down manufacturing processes. This presentation was recorded at the ASQ Salt Lake chapter’s annual symposium on June 13, 2019, at MasterControl headquarters in Salt Lake City, Utah. To get a copy of the slide deck that accompanied this presentation, emails us at podcast@mastercontrol.com and mention the title and presenter of the podcast. For more information about how digital quality and manufacturing solutions can improve your organization, visit MasterControl at mastercontrol.com.
August 14, 2019
47 min
Creating a Strategic Master Validation Plan
Description: Veteran quality and compliance industry consultant Walt Murray shares “Creating a Strategic Master Validation Plan” in which lays out step-by-step how quality and compliance professionals in life sciences and other regulated manufacturers can collaborate with key stakeholders vertically within their organizations to ensure that principles of validation reach across company policies and systems. A strategic master validation plan (SVMP) sets the tone across departments for the nature, depth and extent of documentation needed to execute validation of any given project or software system. Not only does an SVMP act as a guidepost for tracking a project’s progress, but it also inherently provides governance to validation project teams about stakeholder orientation. This podcast was originally recorded at an ASQ industry presentation on Feb. 21, 2019, hosted at MasterControl’s headquarters in Salt Lake City, Utah. To get a copy of the slide deck that accompanied this presentation, emails us at podcast@mastercontrol.com and mention the title and presenter of the podcast. For more information about how digital validation solutions can assist your organization, visit MasterControl at mastercontrol.com/validation/.
July 31, 2019
80 min
Accelerating Business Momentum Through Strategic, Risk-Based Technology Validation
Technology impacts nearly all aspects of a business and can be highly valuable in planning, making confident decisions, and establishing a fully integrated, quality-driven operation. In most organizations, risk and opportunity analysis has become the norm, and optimizing technology is essential for identifying the best course of action for avoiding risks and maximizing opportunities. Ensuring your technology functions as needed to achieve those objectives is best accomplished through risk-based validation. To validate technologies, many companies develop some form of process documentation. One highly recommended strategy is to create a master validation master plan (MVMP). This plan consists of key points to consider when dealing with new, revised, and changed technology scenarios. Also, completing aspect and impact analysis for the various technologies in a business can reveal opportunities to advance the organization toward its objectives. We will examine a model for risk and opportunity analysis for an organization’s validation planning and mapping efforts. Key takeaways: Complete a risk and opportunity planning worksheet. Strategic planning for the various conditions that trigger validation(s). Map an MVMP for an innovative organization.
February 25, 2019
80 min
Jan Olson of EduQuest talks about MasterControl and Cloud vs hosted Systems
Former FDA investigator Jan Olson of EduQuest discusses the pros and cons of cloud servers versus hosted servers in regulated environments. Jan clarifies common misapprehensions about server security concerns and demystifies the groundbreaking cloud technology trends that are catalyzing the regulatory world.
February 1, 2019
9 min

MasterControl - Quality & Compliance Management PodCast

About this podcast

Categories

About this podcast

Categories

MasterControl - Quality & Compliance Management PodCast

Episodes

Navigating Constant Change With Flexible Quality Systems

Manufacturing Technology: Features and Functionality for Changing Environments

The Rise of Intelligent Quality: Shifting to Flexible and Dynamic Processes

The New Ecosystem Dynamics: Digitization as a Driver of Global Quality Alignment and Innovation

Episode 10: Future Proofing – Digital Production Records, QMS and Validation

Episode 9: Future Proofing – Continuing Production Beyond Exemption

Episode 8: Documentation – Quality Event Management and Audit

Episode 7: Documentation – Electronic Batch and Device History Records

Episode 6: Documentation – Standard Operating Procedures (SOPs) and Work Instructions

Episode 5: FDA Current Guidance and Exemptions

Episode 4: ISO vs. cGMP vs. FDA Requirements

Episode 3: Achieving and Maintaining an Audit-Ready State

Episode 2: Elevate Your Quality Management System

Episode 1: An Introduction to Quality Management System (QMS) for Regulated Industry – Next Steps

Cloud Security Myths - Part 2 Security and Validation Webinar Series

Cloud Education - Part 1 Cloud Security and Validation Webinar

Standardize Your On The Job (OJT) With TWI” by Roger Crist

Creating a Strategic Master Validation Plan

Accelerating Business Momentum Through Strategic, Risk-Based Technology Validation

Jan Olson of EduQuest talks about MasterControl and Cloud vs hosted Systems